Skin protectant spray compositions

ABSTRACT

A liquid, water-repellent, substantially anhydrous, spray-pumpable skin protectant composition is disclosed. The composition is designed for spraying directly onto skin, has suitable adherence to the skin, and resists running. The composition contains one or more actives, one or more rheology modifiers, and a carrier. The rheological modifiers can be waxes and/or associative thickeners such as some forms of silica. The carrier can be mineral oil replacement (e.g., isohexadecane, cyclomethicone). Film-forming components also help the composition resist running. One indication for which the composition may be formulated is diaper rash. The active ingredient for diaper rash may be dimethicone and preferably also zinc oxide.

BACKGROUND OF THE INVENTION

[0001] 1. Technical Field

[0002] This invention concerns topical formulations and, moreparticularly, topical skin protectant formulations that can be sprayed.

[0003] 2. Background

[0004] Drugs and other substances are often applied to human skin toprotect it from harmful stimuli. The U.S. Food And Drug Administration(“FDA”) has in the past defined a “skin protectant” as a drug thatprotects injured or exposed skin or mucous membrane surfaces fromharmful or annoying stimuli (21 CFR § 347.3 (1983)). Thus, a “skinprotectant” can be used to protect and/or treat skin in connection withvarious indications, including diaper rash; minor burns; cuts; scrapes;sunburn; chaffed, chapped, cracked, or windburned skin or lips; skinirritation; and oozing and/or weeping of skin caused by poison ivy,poison oak, and/or poison sumac.

[0005] The skin of infants is known to be highly sensitive, particularlyto chemical substances. One common skin problem of infants is diaperdermatitis, more commonly called “diaper rash.” “Diaper rash” has beendefined by the FDA as an inflammatory skin condition in the diaper area(perineum, buttocks, lower abdomen, and inner thighs) caused by one ormore of the following factors: moisture, occlusion, chaffing, continuedcontact with urine or feces or both, or mechanical or chemicalirritation (21 CFR § 347.3 (1990)), and that definition will be usedherein. The FDA has also indicated that mild diaper rash appears assimple erythema and that more severe conditions may be accompanied bypapules, vesicles, oozing, and ulceration. Adults (e.g., incontinentadults) may also suffer from diaper rash.

[0006] Strategies for dealing with diaper rash include removing thesource of irritation, reducing the immediate skin reaction, relievingdiscomfort, and preventing secondary infection. Many products used intreating diaper rash are designed to provide a barrier between the skinand the waste products. Known barrier ingredients include zinc oxide andpetrolatum. Barrier products containing oily substances such aspetrolatum may feel greasy, may be difficult to apply because of theirhigh viscosity, and may not be easily removed from hands that apply theproducts or from the infant's skin. Clean-up of these products from thehands and from the infant's skin may be regarded by some astime-consuming, messy, and inconvenient.

[0007] The FDA will allow claims to be made that the followingsubstances are useful as skin protectants provided, among other things,that those substances are used at FDA-specified concentration levels:mineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,petrolatum, white petrolatum, cod liver oil, lanolin, talc, topicalstarch, aluminum hydroxide gel, cocoa butter, glycerine, shark liveroil, zinc acetate, and zinc carbonate, all of which will be referred toherein as “active ingredients for protecting skin” (21 CFR § 347.10(1983 and 1990)). As used herein, the terms “protecting skin,”“protecting the skin,” and “protecting human skin” are synonymous andeach include protecting and/or treating skin in connection with variousindications involving the skin, including diaper rash; minor burns;cuts; scrapes; sunburn; chaffed, chapped, cracked, or windburned skin orlips; skin irritation; and oozing and/or weeping of skin caused bypoison ivy, poison oak, and/or poison sumac.

[0008] The FDA will allow claims to be made that the followingsubstances are useful in treating diaper rash provided, among otherthings, that those substances are used at FDA-specified concentrationlevels: mineral oil, dimethicone, zinc oxide, allantoin, calamine,kaolin, petrolatum, white petrolatum, cod liver oil, lanolin, talc, andtopical starch, all of which will be referred to herein as “activeingredients for treating diaper rash” (21 CFR § 347.10 (1983 and 1990)).For example, assuming all the other requirements are met, the FDA willallow a claim to be made that a composition containing dimethicone isuseful for treating diaper rash if the dimethicone concentration is from1% w (percent by weight) to 30% w. A similar claim can be made for acomposition containing zinc oxide if the zinc oxide concentration isfrom 1% w to 40% w. A similar claim can be made for a compositioncontaining mineral oil if the mineral oil concentration is from 50% w to100% w. As used herein, the term “treating diaper rash” includestreating an existing diaper rash condition or preventing a diaper rashcondition or both.

[0009] Compositions that may contact the skin and may contain zincoxide, and/or mineral oil, and/or silicon dioxide (silica), and/ordimethicone or other silicone compounds, some of which compositions maybe in the form of aerosols or sprays and some of which compositions maybe used for treating diaper rash, include those compositions referred toin U.S. Pat. Nos. Re. 33,107, 2,843,522, 3,770,648, 3,935,862,4,043,077, 4,196,218, 4,273,786, 4,278,658, 4,329,366, 4,389,418,4,514,383, 4,556,560, 4,569,839, 4,574,082, 4,672,074, 4,725,438,4,800,076, 4,816,254, 4,842,593, 4,847,071, 4,911,932, 4,933,330,4,938,960, 4,996,238, 4,996,239, 5,043,359, 5,085,856, 5,137,714,5,208,031, 5,210,102, 5,232,691, 5,234,689, 5,266,318, 5,362,488,5,389,204, 5,436,007, 5,527,519, 5,543,135, 5,545,673, 5,558,872,5,573,753, 5,576,006, 5,603,863, 5,616,331, 5,635,191, 5,643,588,5,652,274, 5,662,937, 5,665,426, 5,730,993, 5,733,895, 5,744,146,5,756,082, 5,756,110, 5,762,945, 5,776,440, 5,834,290, 5,861,143,5,861,144, 5,861,146, 5,863,522, 5,869,061, 5,869,062, 5,869,071,5,874,094, 5,885,599, 5,914,101, 5,939,053, 5,945,211, 5,958,397,5,961,961, 5,962,441, 5,965,137, 5,965,610, 5,968,531, and 5,972,359.(All of the these documents and any other documents discussed orotherwise referenced or identified herein are incorporated herein intheir entireties for all purposes.)

[0010] Compositions containing zinc oxide that may contact the skininclude those referred to in U.S. Pat. Nos. 2,843,522, 3,770,648,4,034,077, 4,278,658, 4,389,418, 4,556,560, 4,569,839, 4,672,074,4,816,254, 4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691,5,527,519, 5,543,135, 5,545,673, 5,573,753, 5,603,863, 5,616,331,5,652,274, 5,662,937, 5,665,426, 5,730,993, 5,733,895, 5,744,146,5,756,110, 5,762,945, 5,834,290, 5,861,143, 5,861,144, 5,861,146,5,863,522, 5,869,062, 5,874,094, 5,885,599, 5,914,101, 5,939,053,5,945,211, 5,961,961, 5,962,441, 5,965,610, 5,968,531, and 5,972,359.

[0011] Some of the compositions containing zinc oxide may be sprayable(with or without a propellant). See, e.g., U.S. Pat. Nos. 3,770,648,4,278,658, 4,933,330, 5,652,274, 5,733,895, 5,834,290, 5,861,143,5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,939,053, 5,945,211,5,962,441, 5,965,610, and 5,972,359.

[0012] Some of the compositions containing zinc oxide may contain smallzinc oxide particles (e.g., less than 1 micron). See, e.g., U.S. Pat.Nos. 5,543,135, 5,527,519, 5,573,753, 5,603,863, 5,616,331, 5,730,993,5,756,110, 5,861,143, 5,861,144, 5,861,146, 5,914,101, 5,945,211,5,961,961, and 5,972,359.

[0013] Topical compositions for treating diaper rash containing zincoxide include DESITIN® Ointment and DESITIN® Creamy Ointment, bothmarketed by Pfizer Inc, the assignee of the present application.DESITIN® Ointment contains about 40% w zinc oxide and other ingredients,including white petrolatum, cod liver oil, lanolin, talc, and about 5% wwater. DESITIN® Creamy Ointment contains about 10% w zinc oxide andother ingredients, including mineral oil, mineral wax, dimethicone,cyclomethicone, white petrolatum, white wax, and over 30% w water.

[0014] Other diaper rash, incontinence/dermatitis, diaper-treating, andbaby treatment compositions include those referred to in U.S. Pat. Nos.Re. 33,107, 2,843,522, 3,770,648, 3,935,862, 4,034,077, 4,273,786,4,329,366, 4,556,560, 4,816,254, 4,842,593, 4,911,932, 4,996,238,4,996,239, 5,362,488, 5,436,007, 5,576,006, 5,558,872, 5,635,191,5,643,588, 5,652,274, 5,762,945, 5,834,290, 5,869,071, and 5,945,211.

[0015] Some of those diaper rash, incontinence/dermatitis,diaper-treating, and baby treatment compositions may form a film whenthey are topically applied and may be resistant to wetting by moisture.See, e.g., U.S. Pat. No. 4,996,238 (column 2, line 20 and following) andU.S. Pat No. 4,996,239(column 2, line 40 and following).

[0016] Some of those diaper rash, incontinence/dermatitis,diaper-treating, and baby treatment compositions may containfilm-forming agents. See, e.g., U.S. Pat. No. 4,996,238 (column 2, line42 and following), U.S. Pat. No. 4,996,239 (column 2, line 63 andfollowing), U.S. Pat. No. 5,635,191 (column 18, line 34), and U.S. Pat.No. 5,643,588 (column 18, line 47).

[0017] Some of those diaper rash, incontinence/dermatitis,diaper-treating, and baby treatment compositions may be sprayable (withor without a propellant). See, e.g., U.S. Pat. Nos. Re. 33,107,3,770,648, 3,935,862, 4,273,786, 4,329,366, 4,842,593, 5,436,007,5,576,006, 5,635,191, 5,643,588, 5,652,274, 5,869,071, and 5,945,211.

[0018] U.S. Pat. No. Re. 33,107 refers to sprays that may containmineral oil for treating skin conditions such as dermatitis.

[0019] U.S. Pat. No. 3,770,648, assigned on its face to Bristol-MyersCompany, refers to substantially non-aqueous quick-breaking aerosolfoaming compositions containing silicone compounds (e.g., dimethylsilicone fluids), foamable organic liquids (e.g., mineral oil), and ahigh vapor pressure propellant system (e.g., fluorocarbons). Example 2of the patent refers to what is called “DESITIN® baby foam,” containingzinc oxide (about 4.2% w), mineral oil (about 71.7% w), a silicone, andFREON 12 fluorocarbon propellant.

[0020] U.S. Pat. Nos. 3,935,862 and 4,273,786 refer to compositionscontaining amino acid compounds to inhibit the formation of ammonia andtherefore treat diaper rash. The compositions may contain solid diluentssuch as starch and talc and may also contain silicone-type fluids suchas polysiloxane fluid. Although mineral oil is referred to in some ofthe non-sprayable compositions exemplified in the patents, the onlysprayable composition (Example H) contains micropulverized talc, anamino acid salt, fragrance, anhydrous ethanol, isopropyl myristate, andtwo FREON propellants.

[0021] U.S. Pat. No. 4,329,366 refers to compositions containingacylaminophenols that can be used to treat various conditions, includingdiaper rash. Although mineral oil is referred to in some of thenon-sprayable formulations exemplified, the two sprayable formulations(Formulations F and L) use alcohol and propellants and at least one ofthem (Formulation F) contains water.

[0022] U.S. Pat. No. 4,842,593 refers to a pH control system that can besprayed onto an article used to prevent or reduce diaper rash. Thefibers of the article may be impregnated with silica.

[0023] U.S. Pat. No. 5,436,007 refers to a diaper rash lotion that maybe sprayed containing dimethicone (e.g., from 1% w to 30% w), water(e.g., from 50% w to 95% w), and an emulsifier (e.g., from 1% w to 10%w). The patent also refers to a diaper rash cream that may contain alinear polydimethylsiloxane (e.g., 20% w), a light mineral oil (e.g., 4%w), emulsifier (e.g., 8% w), and water (e.g., over 40% w). Stearic acid,which is said to function as a thickener, and aloe may also be used inthe lotion and the cream. See, e.g., column 7, line 6, to column 10,line 26.

[0024] U.S. Pat. No. 5,576,006 refers to antibacterial compositions thatcan be used to deodorize footwear and to treat diaper rash. Although thefootwear deodorizing compositions can be sprays, it appears that thecompositions intended for use on infants are “body preparations andpowders,” which may contain talc (column 3, lines 47-63, and Example 3).The sprays exemplified contain water.

[0025] U.S. Pat. Nos. 5,635,191 and 5,643,588 refer to a diaper having atopsheet coated with a composition containing emollients (such asmineral oil, petrolatum or mineral wax, and polysiloxanes) and otheringredients (such as viscosity modifiers and film formers). Thecomposition may be sprayed onto the topsheet. According to the patents,the composition on the diaper topsheet is transferred to the wearer'sskin and those topsheets provide “BM [bowel movement] cleaning,therapeutic or protective lotion coating benefits” (U.S. Pat. No.5,635,191, column 2, line 64, to column 3, line 52; and U.S. Pat. No.5,643,588, column 2, line 62, to column 3, line 51). The composition is“solid” or “semisolid” at 20 degrees Centigrade (U.S. Pat. No.5,635,191, column 9, lines 35-67; and U.S. Pat. No. 5,643,588, column 9,line 39, to column 10, line 4) and is “substantially free of water”(U.S. Pat. No. 5,635,191, column 10, lines 43-54, and U.S. Pat. No.5,643,588, column 10, lines 48-59).

[0026] U.S. Pat. No. 5,652,274 refers to therapeutic wound healingcompositions. Compositions for treating diaper dermatitis are discussed,for example, at column 11, lines 31-49; column 15, lines 39-61; column26, lines 5-26; and column 138, line 52, to column 145, line 4. Thosecompositions may contain zinc oxide. At least some compositions may besprayed (for example, the formulations of Embodiment One; see column 42,line 26). Some of the compositions may contain petrolatum, mineral oil,and vitamin E (see, e.g., column 66, lines 35-49).

[0027] U.S. Pat. No. 5,869,071 refers to a spray composition forincontinent patients that “cleanses, moisturizes and leaves a protectivepetrolatum barrier against wetness and irritants in one step” (column 1,lines 58-63). The composition is said to be an emulsion of water andpetrolatum (or petroleum jelly) and may contain dimethicone,cyclomethicone, mineral oil, vitamin E, and aloe.

[0028] U.S. Pat. No. 5,945,211 refers to a composite to which zinc oxideparticles are adhered. The composite may be a diaper and the zinc oxidemay be deposited on the composite from an aqueous medium (e.g., byspraying an aqueous suspension of zinc oxide).

[0029] Sprayable (with or without a propellant) compositions that maycontact the skin and that may contain dimethicone or other siliconcompounds include those referred to in U.S. Pat. Nos. 3,770,648,3,935,862, 4,273,786, 4,514,383, 4,847,071, 4,933,330, 5,137,714,5,266,318, 5,389,204, 5,436,007, 5,635,191, 5,643,588, 5,733,895,5,776,440, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,869,071, 5,885,599, 5,939,053, 5,962,441, 5,965,610, and 5,972,359.

[0030] Compositions containing some form of silica (silicon dioxide)include those referred to in U.S. Pat. Nos. 4,574,082, 4,800,076,4,996,238, 4,996,239, 5,137,714, 5,208,031, 5,527,519, 5,543,135,5,573,753, 5,603,863, 5,616,331, 5,733,895, 5,756,082, 5,756,110,5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599,5,914,101, 5,939,053, 5,968,531, and 5,972,359. Some forms of silica aresaid to be useful as thickeners. See, e.g., U.S. Pat. Nos. 4,996,238 and4,996,239.

[0031] Some of those compositions containing some form of silica alsomay contain zinc oxide. See, e.g., U.S. Pat. Nos. 5,208,031, 5,527,519,5,543,135, 5,573,753, 5,603,863, 5,616,331, 5,733,895, 5,756,110,5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599,5,914,101, 5,939,053, 5,968,531, and 5,972,359.

[0032] Some of those compositions containing silica (with or withoutzinc oxide) may be sprayable. See, e.g., U.S. Pat. Nos. 5,137,714,5,733,895, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,5,885,599, 5,939,053, and 5,972,359.

[0033] Some sprayable compositions may contain aloe and/or a form ofvitamin E. See, e.g., U.S. Pat. Nos. 4,847,071, 5,266,318, 5,436,007,5,861,143, 5,861,144, 5,861,146, 5,869,071, 5,885,599, 5,965,137,5,965,610, and 5,972,359. Some of the composition containing aloe and/ora form of vitamin E may be for treating diaper rash and/orincontinence/dermatitis. See, e.g., U.S. Pat. Nos. 5,436,007 and5,869,071.

[0034] Compositions containing (a) mineral oil or petrolatum, (b) zincoxide, and (c) dimethicone or other silicone ingredient include thosereferred to in U.S. Pat. Nos. 3,770,648, 4,389,418, 4,556,560,4,569,839, 4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691,5,543,135, 5,603,863, 5,616,331, 5,665,426, 5,730,993, 5,733,895,5,744,146, 5,756,110, 5,834,290, 5,861,143, 5,861,144, 5,861,146,5,863,522, 5,885,599, 5,914,101, 5,939,053, 5,961,961, 5,962,441,5,965,610, and 5,972,359. Some of those compositions may be sprayable(with or without a propellant). See, e.g., U.S. Pat. Nos. 3,770,648,4,933,330, 5,733,895, 5,834,290, 5,861,143, 5,861,144, 5,861,146,5,863,522, 5,885,599, 5,939,053, 5,962,441, 5,965,610, and 5,972,359.Some of those compositions may be for treating diaper rash. See, e.g.,U.S. Pat. Nos. 4,556,560 and 4,911,932.

[0035] Some of those compositions containing (a) mineral oil orpetrolatum, (b) zinc oxide, and (c) dimethicone or other siliconeingredient may also contain silica. See, e.g., U.S. Pat. Nos. 5,208,031,5,543,135, 5,603,863, 5,616,331, 5,733,895, 5,756,110, 5,834,290,5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,914,101,5,939,053, and 5,972,359. Some of those compositions may be sprayable(with or without a propellant). See, e.g., U.S. Pat. Nos. 5,733,895,5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599,5,939,053, and 5,972,359.

[0036] Some of those compositions containing (a) mineral oil orpetrolatum, (b) zinc oxide, and (c) dimethicone or other siliconeingredient may also contain wax. See, e.g., U.S. Pat. Nos. 4,389,418,4,556,560, 4,569,839, 4,911,932, 4,933,330, 5,085,856, 5,208,031,5,232,691, 5,616,331, 5,665,426, 5,730,993, 5,733,895, 5,744,146,5,834,290, 5,863,522, 5,939,053, and 5,961,961. Some of thosecompositions may be sprayable (with or without a propellant). See, e.g.,U.S. Pat. Nos. 4,933,330, 5,733,895, 5,834,290, 5,863,522, and5,939,053.

[0037] Despite all the work done in this technical area, the need stillexists for a safe and effective liquid skin protectant composition thatis liquid, is water-repellent, substantially anhydrous, can be applieddirectly to the skin, quickly, easily, and without messing one's handswith the composition, and that will not run after it has been applied tothe skin. Moreover, the need still exists for such a composition thatcan be applied to the skin without the need to use high-pressure such asthat provided by propellant gas in an aerosol can. Furthermore, the needstill exists for a composition meeting all those criteria that can beused for treating diaper rash.

SUMMARY OF THE INVENTION

[0038] A composition that can satisfy some or all of those needs andprovides other benefits that will be apparent to one skilled in the arthas now been developed. Broadly, the composition of this invention is askin-protectant composition comprising:

[0039] (a) at least about 0.001% w of at least one active ingredient forprotecting skin;

[0040] (b) at least about 0.001% w of at least one rheology modifier;and

[0041] (c) carrier;

[0042] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.

[0043] Another aspect of the invention concerns a skin-protectantcomposition comprising:

[0044] (a) at least about 0.001% w of at least one active ingredient forprotecting skin;

[0045] (b) at least about 0.001% w of a rheology modifier that is anassociative thickener and optionally at least about 0.001% w of at leastone additional rheology modifier; and

[0046] (c) carrier;

[0047] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.

[0048] Another aspect of the invention concerns a skin-protectantcomposition comprising:

[0049] (a) at least about 0.001% w of at least one active ingredient forprotecting skin;

[0050] (b) at least about 0.001% w of a rheology modifier that is anassociative thickener and optionally at least about 0.001% w of at leastone additional rheology modifier;

[0051] (c) at least about 0.001% w of at least one film-forming agent;and

[0052] (d) carrier;

[0053] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.

[0054] Another aspect of the invention concerns a skin-protectantcomposition comprising:

[0055] (a) at least about 0.1% w of at least one active ingredient forprotecting skin;

[0056] (b) at least about 0.1% w of a rheology modifier that is anassociative thickener comprising silica and optionally at least about0.1% w of at least one additional rheology modifier;

[0057] (c) at least about 0.1% w of at least one polymeric film-formingagent; and

[0058] (d) carrier;

[0059] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.

[0060] Another aspect of the invention concerns a skin-protectantcomposition comprising:

[0061] (a) at least about 0.001% w of at least one active ingredient forprotecting skin;

[0062] (b) at least about 0.001% w of at least one rheology modifierthat is an associative thickener and optionally at least about 0.001% wof at least one additional rheology modifier that is a wax;

[0063] (c) at least about 0.001% w of at least one polymericfilm-forming agent selected from the group consisting ofsilicon-containing polymers and synthetic waxes; and

[0064] (d) carrier;

[0065] wherein the composition is liquid, water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.

[0066] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0067] (a) at least about 0.1% w of at least one active ingredient fortreating diaper rash;

[0068] (b) at least about 0.1% w of at least one rheology modifier;

[0069] (c) at least about 0.1% w of at least one film-forming agent; and

[0070] (d) carrier;

[0071] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0072] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0073] (a) at least about 1% w of dimethicone;

[0074] (b) at least about 0.5% w of at least one rheology modifierselected from the group consisting of associative thickeners and waxes;

[0075] (c) at least about 0.2% w of at least one polymeric film-formingagent; and

[0076] (d) carrier;

[0077] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0078] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0079] (a) at least about 1% w of dimethicone;

[0080] (b) at least about 1% w of zinc oxide;

[0081] (c) at least about 1% w of wax;

[0082] (d) at least about 1% w of an associative thickener;

[0083] (e) at least about 0.2% w of at least one polymeric film-formingagent; and

[0084] (f) carrier selected from the group consisting of mineral oil andmineral oil replacements;

[0085] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0086] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0087] (a) at least about 1% w of dimethicone;

[0088] (b) at least about 1% w of mineral wax;

[0089] (c) at least about 0.5% w of silica;

[0090] (d) at least about 0.1% w of a silicon-containing polymericfilm-forming agent;

[0091] (e) at least about 0.1% w of a synthetic wax polymericfilm-forming agent;

[0092] (i) at least about 2% w cyclomethicone;

[0093] (g) at least about 2% w isohexadecane; and

[0094] (h) at least about 50% w mineral oil;

[0095] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0096] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0097] (a) from about 0.8% w to about 1.2% w of dimethicone;

[0098] (b) from about 4% w to about 6% w of mineral wax;

[0099] (c) from about 1.8% w to about 2.8% w of silica;

[0100] (d) from about 0.8% w to about 1.2% w of a silicon-containingpolymeric film-forming agent;

[0101] (e) from about 1.6% w to about 2.4% w of a synthetic waxpolymeric film-forming agent;

[0102] (f) from about 7.2% w to about 10.8% w cyclomethicone;

[0103] (g) from about 5.2% w to about 7.8% w isohexadecane; and

[0104] (h) from about 57% w to about 85% w mineral oil;

[0105] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0106] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0107] (a) at least about 1% w of dimethicone;

[0108] (b) at least about 1% w of zinc oxide;

[0109] (c) at least about 1% w of mineral wax;

[0110] (d) at least about 0.5% w of silica;

[0111] (e) at least about 0.1% w of a silicon-containing polymericfilm-forming agent;

[0112] (f) at least about 0.1% w of a synthetic wax polymericfilm-forming agent;

[0113] (g) at least about 2% w cyclomethicone;

[0114] (h) at least about 2% w isohexadecane; and

[0115] (i) at least about 50% w mineral oil;

[0116] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0117] Another aspect of the invention concerns a diaper rashcomposition comprising:

[0118] (a) from about 0.8% w to about 1.2% w of dimethicone;

[0119] (b) from about 8% w to about 12% w of zinc oxide;

[0120] (c) from about 1.8% w to about 2.7% w of mineral wax;

[0121] (d) from about 1.7% w to about 2.5% w of silica;

[0122] (e) from about 0.4% w to about 0.6% w of a silicon-containingpolymeric film-forming agent;

[0123] (f) from about 1.0% w to about 1.6% w of a synthetic waxpolymeric film-forming agent;

[0124] (g) from about 6.8% w to about 10.2% w cyclomethicone;

[0125] (h) from about 4.5% w to about 6.7% w isohexadecane; and

[0126] (i) from about 53% w to about 80% w mineral oil;

[0127] wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.

[0128] Another aspect of this invention concerns a hand-held spray pumpdispenser containing and for spraying the composition of this invention.

[0129] Another aspect of this invention concerns a method of protectinghuman skin comprising applying the composition of this invention tohuman skin.

[0130] Another aspect of this invention concerns a method of treatingdiaper rash in a human comprising applying the composition of thisinvention to human skin.

[0131] The composition of this invention is safe, effective, and can beapplied directly to the skin (i.e., by spraying). Spraying obviates theneed to first put the composition on one's hands or on an applicationdevice and then rub it onto the skin of a baby or other human being.Such rubbing on skin already affected with, for example, diaper rashwould likely cause discomfort. The composition of this invention isstorage-stable, even though it can contain a significant concentrationof solids, such as zinc oxide particles. The composition can be sprayedusing a hand-held pump sprayer (a hand-held spray pump dispenser), thatis, without the need to use a pressurized (e.g., propellant-containing)device. Hand-held spray pump dispensers are easier to use, moreenvironmentally friendly, and their use avoids having a pressurizedcontainer used near, for example, an infant. The composition of thisinvention tends to resist running after it has been applied to the skin,and it has a reduced greasy feel.

[0132] Further aspects, features, and advantages of this invention willbecome apparent to those skilled in the art from the description of theinvention herein.

DETAILED DESCRIPTION OF THE INVENTION

[0133] The composition of this invention is a liquid, water-repellent,substantially anhydrous, spray-pumpable composition that is designed forspraying onto the skin of a baby or other human being for protectingskin (e.g., for treating diaper rash). It is believed that thiscomposition is the first skin protectant spray composition that, amongother things, is liquid, is designed for direct application to the skinof a human being (including to the tender skin of a baby), isefficacious in protecting the skin to which it is applied, has suitableadherence to the skin, can contain particles (e.g., of silica), isstorage-stable, water-repellent, substantially anhydrous, andspray-pumpable, and resists running. It is also believed that the diaperrash spray embodiment is the first diaper rash spray composition of itstype that, among other things, is liquid, is designed for directapplication to the tender skin of a baby, provides efficacious treatmentof diaper rash, has suitable adherence to the skin, can contain zincoxide particles, is storage-stable, water-repellent, substantiallyanhydrous, and spray-pumpable, and resists running.

[0134] By “liquid” is meant that at 20 degrees Centigrade underatmospheric pressure the substance in question has a continuous liquidphase and otherwise meets the definition of a liquid. For example, thecomposition of this invention is liquid before being sprayed because ithas a continuous liquid phase at 20 degrees Centigrade under atmosphericpressure. Thus, for example, the presence of solid particles (e.g., ofzinc oxide and/or silica) in the composition does not prevent it frombeing considered to be a “liquid” composition.

[0135] By “water-repellent” is meant that the composition when on theskin substantially impedes the passage of liquid water through thecomposition for a sufficiently long period of time. Thus, for example,in the case of a diaper rash composition of this invention, thecomposition is water-repellent because it impedes the passage of waterfor at least what is a typical period of time between diaper changes(e.g., three hours, five hours, seven hours, or in some cases evenlonger).

[0136] By “substantially anhydrous” is meant that the water content ofthe composition will be less than about 5% w by weight, typically lessthan about 3% w, desirably less than about 2% w, more desirably lessthan about 1% w, most desirably less than about 0.5% w, preferably lessthan about 0.3% w, more preferably less than about 0.1% w, and mostpreferably less than about 0.05% w. Although no water preferably isintentionally added as a separate ingredient when making thecomposition, it is possible that some of the ingredients used toformulate the composition may contain trace quantities of water. If anywater is present in the composition of this invention, there desirablyis no “free” (i.e., non-emulsified) water and, therefore, theredesirably is no separate water phase. Thus, preferably, at least as maybe observed using normal human vision (i.e., 20/20) without the aid ofany magnifying or detection equipment, no separate aqueous layer formswhen the composition of this invention stands for 24 hours at 20 degreesCentigrade in a closed container padded with inert gas.

[0137] The presence of free water in the composition tends to adverselyaffect the physical and other properties of the composition. More freewater could create a discrete water layer and/or increase the surfacetension of the composition (reducing the ability of the composition to“wet” the working parts of the spray pump dispenser and thereby beeasily sprayed) and/or decrease the composition's adherence to the skin(tackiness) and/or increase its “runnyness” (i.e., the tendency of thecomposition to run off the skin to which it has been applied because ofgravity or other force). Thus, free (i.e., non-emulsified) water in alayer of composition on skin being protected (which includes beingtreated) is believed to reduce the efficacy of the composition for itsintended purpose of protecting skin (e.g., treating diaper rash) byreducing the sprayability of the composition, by reducing the barrierproperties of the composition (including making the composition lesswater-repellent), and by making it easier for the composition toprematurely leave the skin being treated (e.g., to prematurely rub offor prematurely flow off under the force of gravity). If the compositionwere formulated to contain water, it would be necessary to add anemulsifier; however, it is a feature of this invention that thecomposition can be “emulsifier-free.” Preferably the composition isemulsifier-free. Including an emulsifier in the composition (so that anywater present is not “free”) would tend to make the composition lessspray-pumpable and less water-repellent, and it is a feature of thisinvention that the composition is spray-pumpable and water-repellent.

[0138] By “spray-pumpable” is meant that a hand-held spray pumpdispenser can be used to dispense the composition, which is liquid at 20degrees Centigrade under normal atmospheric pressure, by spraying usingnormal finger pressure on the portion of the spray pump assemblydesigned to be activated by finger pressure. By “spray” is meant a jetof finely divided liquid composition. (See, e.g., U.S. Pat. Nos.3,159,316, 4,034,900, and 4,050,860, which show different spray pumpdispensers.) The hand-held spray pump dispenser used to dispense (spray)a composition of this invention typically contains the composition atatmospheric pressure and it is only when finger pressure is applied thatthe spray pump mechanism temporarily pressurizes the composition tocause a portion of it to leave the dispenser as a spray. The pressure inthe mechanism soon returns to atmospheric after the small portion ofcomposition has been dispensed. Such a hand-held spray pump dispenser isconsidered to be a non-pressurized dispenser. In other words, a featureof this invention is that a hand-held spray pump dispenser (i.e., anon-pressurized dispenser) can be used in its normal manner to dispensethe composition of this invention.

[0139] “Spray cans” or “aerosol cans,” which use propellants (e.g., aFREON or other fluid having a vapor pressure at 20 degrees Centigradesignificantly higher than atmospheric pressure), are well-known types ofpressurized dispensers. Another type of pressurized dispenser is onehaving a resilient deformable bladder that has been force-filled withenough mass to cause it to expand. The memory of the resilient bladdermaterial causes it to try to return to its original, non-deformed sizeand shape, which thereby pressurizes the mass inside the bladder.Another type of pressurized dispenser is a motor-driven pump (e.g., acentrifugal pump, a positive displacement pump).

[0140] The higher pressures that are provided by pressurized dispensersare not needed to dispense (spray) the composition of this invention,although in some cases they may be used. The fact that a spray-pumpablecomposition of this invention is also able to be dispensed using apressurized dispenser (e.g., a dispenser containing a propellant, adispenser containing a resilient expanded bladder, a motor-driven pump)does not mean that the composition is not spray-pumpable; however,hand-held spray pump dispensers (i.e., non-pressurized dispensers) arepreferred for use in spraying the composition of this invention onto theskin to be treated. Broadly speaking, hand-held spray pump dispensersare less expensive, more economical, and more environmentally friendlythan pressurized dispensers.

[0141] It is not believed that any special design for the hand-heldspray pump dispenser is needed, although some adjustment of specificdimensions and/or materials of construction may be needed because of thephysical and chemical properties of the particular composition to bedispensed. As will be understood by those skilled in the art, theparticular design of the spray pump dispenser is not critical and anyhand-held spray pump dispenser that allows appropriate dispensing of thecomposition of this invention, in which the composition is sufficientlystorage-stable, and which itself is not adversely affected by thecomposition (e.g., by prolonged storage) can be used. Broadly speaking,spray pump dispensers are affected to some degree by the compositionsthey contain and dispense. For example, storage of the composition inthe spray pump dispenser in warm weather over an extended period maycause swelling of the different parts of the spray pump dispenser todiffering degrees. That in turn may adversely affect operation of thespray pump and dispensing (spraying) of the composition. Selection of ahand-held spray pump dispenser design and of suitable materials ofconstruction are well within the skill of the art.

[0142] The terms “protecting skin,” “protecting the skin,” and“protecting human skin” are synonymous, have been defined above, andeach include protecting and/or treating skin in connection with variousindications involving the skin, including diaper rash; minor burns;cuts; scrapes; sunburn; chaffed, chapped, cracked, or windburned skin orlips; skin irritation; and oozing and/or weeping of skin caused bypoison ivy, poison oak, and/or poison sumac.

[0143] The term “diaper rash” has been defined above as an inflammatoryskin condition in the diaper area (perineum, buttocks, lower abdomen,and inner thighs) caused by one or more of the following factors:moisture, occlusion, chaffing, continued contact with urine or feces orboth, or mechanical or chemical irritation. Thus, “diaper rash” is thewell-known condition often suffered by babies and older incontinentpeople as a result of their wearing diapers or the like (e.g.,incontinence pads). Diaper rash may also be referred to as “diaperdermatitis” or “incontinence dermatitis.”

[0144] The term “treating diaper rash” has been defined above andincludes treating an existing diaper rash condition or preventing adiaper rash condition or both.

[0145] A composition that is “designed for spraying onto the skin of ababy or other human” is a sprayable composition that will not harm theskin of any human being, not even the more delicate (tender) skin of ababy, will not be toxic, will not cause irritation, will not bemalodorous, will not decompose to cause any harmful reactions, will notadversely affect any diaper or other substrate that may be in contactwith the composition, etc. Compositions “designed for spraying onto theskin of a baby or other human” include compositions designed to besprayed onto the skin of babies or other human beings for any indicationfor which a skin protectant is used.

[0146] A composition that is “designed for spraying onto the skin of ababy or other human for protecting the skin” is a composition that is“designed for spraying onto the skin of a baby or other human” and isefficacious for the purpose of protecting the skin.

[0147] A composition that is “designed for spraying onto the skin of ababy or other human for treating diaper rash” is a composition that is“designed for spraying onto the skin of a baby or other human” and isefficacious for the purpose of treating diaper rash.

[0148] A composition of this invention that has “suitable adherence tothe skin” will after being applied to the skin remain adhered to theskin long enough under normal conditions of use to have an efficaciouseffect (for example, for treating diaper rash). A layer of compositionon the skin may be thought of as a stack of parallel thin layers, eachlayer being at least one molecule thick. With a composition that hassuitable adherence to the skin, the composition's molecular layerclosest to the skin (the bottom molecular layer) will temporarily bondphysically and/or chemically to the skin on a molecular level, thecomposition's molecular layer above the bottom molecular layer willtemporarily bond physically and/or chemically to that bottom molecularlayer, and so on. The bonds between the skin and the bottom molecularlayer and between the successive molecular layers cannot be permanent orelse it would be difficult to remove the composition from the skin.

[0149] If a composition “resists running,” the composition will not, forexample, under the force of gravity, easily or quickly flow from theskin to which it has been applied. The ability to “resist running” inany particular case depends not only on the physical and chemicalproperties of the composition itself, but also on variables such as thethickness of the layer of composition applied to the skin and thecondition (e.g., oiliness, cleanliness) of the skin to which thecomposition was applied. The rheology modifiers, optional film-formingagents, and optional volatile carrier ingredients used in thecomposition help it resist running.

[0150] The ability of a composition of this invention to resist runningwas compared to the ability of two compositions outside the scope ofinvention to resist running. All of the test runs were performed at roomtemperature (about 20 degrees Centigrade). The preferred zincoxide-containing composition of this invention (described in detailbelow) was placed in a dispenser that dispenses as a spray nominally0.13 milliliters of composition per pump. The spray nozzle was held 2inches (about 5.1 centimeters) above a piece of FORMICA plastic laminatelying flat on a horizontal work surface so that the centerline of thedispensing aperture in the nozzle was perpendicular to the surface ofthe laminate, and three “pumps” of composition were dispensed (a totalof nominally 0.39 milliliters of composition). The resulting circleformed on the laminate surface by the sprayed composition was 1.5 inches(about 3.8 centimeters) in diameter. The piece of plastic laminate wasrotated to a vertical position so that the plane of the circle wasperpendicular to the horizontal work surface, and a line 4 inches (about10.2 centimeters) below the bottom of the circle and parallel to thehorizontal work surface was established. The preferred zincoxide-containing composition of this invention did not run down from its1.5-inch circle, much less traverse the 4 inches (about 10.2centimeters), even after 2 hours.

[0151] The test was also performed on two compositions outside the scopeof the invention: (1) a liquid consisting of only the mineral oil usedin the preferred zinc oxide-containing composition and (2) a liquidconsisting of 99% w of that mineral oil and 1% w of the dimethicone usedin the preferred zinc oxide-containing composition. The 100% w mineraloil flowed down the surface of the plastic laminate and traversed thedistance of 4 inches (about 10.2 centimeters) in less than a second. Theliquid consisting of 99% w mineral oil and 1% w dimethicone flowed downthe surface of the plastic laminate and traversed the distance of 4inches (about 10.2 centimeters) in about 4 seconds.

[0152] As used herein, the term “resists running” means that when acomposition is tested in this manner, if it is going to flow at all, itrequires at least about 10 seconds to traverse (flow down) the 4 inches(in other words, it “resists running for at least about 10 seconds”),usually at least about 15 seconds to traverse the 4 inches (it “resistsrunning for at least about 15 seconds”), typically at least about 20seconds to traverse the 4 inches (it “resists running for at least about20 seconds”), desirably at least about 30 seconds to traverse the 4inches (it “resists running for at least about 30 seconds”), moredesirably at least about 45 seconds to traverse the 4 inches (it“resists running for at least about 45 seconds”), most desirably atleast about 1 minute to traverse the 4 inches (it “resists running forat least about 1 minute”), preferably at least about 2 minutes totraverse the 4 inches (it “resists running for at least about 2minutes”), more preferably at least about 5 minutes to traverse the 4inches (it “resists running for at least about 5 minutes”), mostpreferably at least about 10 minutes to traverse the 4 inches (it“resists running for at least about 10 minutes”), and in some cases, itrequires at least about 30 minutes to traverse the 4 inches (it “resistsrunning for at least about 30 minutes”). The most preferred compositionsdo not traverse the 4 inches even after an hour or more and thereforemay be said to “resist running” (they “resist running for at least about1 hour”).

[0153] These tests demonstrate that the preferred zinc oxide-containingcomposition of this invention “resists running” and that neither of theother two compositions that were tested “resists running.” The lattertwo compositions are outside the scope of the invention because, forexample, neither contains a rheology modifier and neither resistsrunning. The test performed with the preferred zinc oxide-containingcomposition also demonstrates that it has suitable adherence to theskin.

[0154] The composition of this invention has the appropriate rheology tobe spray-pumpable (i.e., to have a low enough viscosity under shear) aswell as to resist running after it has been applied to skin (i.e., tohave a high enough viscosity when not under shear). That arises in partfrom the fact that one or more rheology modifiers are used to make theviscosity of the composition generally decrease as the shear on itincreases (i.e., the composition may be pseudoplastic or thixotropic).Thus, as the composition that had been at rest (i.e., not flowing) inthe spray pump dispenser starts to move, for example, up a tube insidethe spray pump dispenser, the shear increases and the viscosity of thecomposition decreases. As the composition continues to move, forexample, in a narrowing passage towards the small aperture in the nozzleof the spray pump dispenser, the shear continues to increase and theviscosity continues to decrease. The shear may be at a maximum, and theviscosity at a minimum, as the composition passes through the aperturein the nozzle and leaves the spray pump dispenser.

[0155] After the composition comes to rest on the skin, the force beingapplied to the composition is substantially less than when thecomposition was being forced to move inside the spray pump dispenser andthrough the aperture. Accordingly, the viscosity of the composition onthe skin may become essentially the same as the viscosity of thecomposition when it was at rest inside the spray pump dispenser (and maybecome even higher if volatile carrier ingredients evaporate, which iswhat desirably happens with the compositions of this invention). Thisreturn to higher viscosity as the shear decreases plus the optional useof one or more film-forming agents help the composition resist runningon the skin. In short, a “rheology modifier” is a substance otherwisesuitable for incorporation into a composition of this invention thathelps impart to the composition the needed transport properties and makeit, for example, pseudoplastic or thixotropic.

[0156] Broadly, the composition of this invention contains at least oneactive ingredient for protecting skin, at least one rheology modifier,and a carrier. A preferred embodiment of this invention contains atleast one active ingredient for treating diaper rash, at least onerheology modifier, and a carrier. The composition of this inventiondesirably also contains at least one film-forming agent. Variousoptional ingredients include colorants, fragrances, anti-microbials,preservatives, emollients, conditioners, adherence-promoting agents,water-resistance agents, and water-proofing agents.

[0157] The term “active ingredients for protecting skin” includesmineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,petrolatum, white petrolatum, cod liver oil, lanolin, talc, topicalstarch, aluminum hydroxide gel, cocoa butter, glycerine, shark liveroil, zinc acetate, and zinc carbonate. The term “active ingredients forprotecting skin” also includes other substances that are now or may inthe future be efficacious for protecting skin, provided they can besuccessfully used alone or in combination with other active ingredientsto form a composition of this invention.

[0158] The term “active ingredients for treating diaper rash” includesmineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,petrolatum, white petrolatum, cod liver oil, lanolin, talc, and topicalstarch. The term “active ingredients for treating diaper rash” alsoincludes other substances that are now or may in the future beefficacious for treating diaper rash, provided they can be successfullyused alone or in combination with other active ingredients to form acomposition of this invention. Of the active ingredients listed above,dimethicone is preferred and a combination of dimethicone and zinc oxideis most preferred.

[0159] The concentration of the one or more active ingredients forprotecting skin should be at least about 0.001% w, usually at leastabout 0.01% w, desirably at least about 0.1% w, and preferably at leastabout 1% w. In some cases, the concentration will be at least about 5%w, at least about 10% w, or even at least about 50% w. The FDA allows aclaim to be made that dimethicone is present in a composition as anactive ingredient for treating diaper rash if its concentration in thecomposition in question is from 1% w to 30% w (and providing other FDArequirements are met). The corresponding range for zinc oxide undercurrent FDA regulations is from 1% w to 40% w. The corresponding rangefor mineral oil is from 50% w to 100% w.

[0160] The limitation “at least about 0.001% w of at least one activeingredient for protecting skin” is satisfied or met (a) if any activeingredient for protecting skin is present in a concentration of at leastabout 0.001% w or (b) if two or more active ingredients for protectingskin are present in a total concentration of at least about 0.001% weven if none of the active ingredients for protecting skin isindividually present in a concentration of at least about 0.001% w.Similarly, the limitation “at least about 0.1% w of at least one activeingredient for treating diaper rash” is satisfied or met (a) if anyactive ingredient for treating diaper rash is present in a concentrationof at least about 0.1% w or (b) if two or more active ingredients fortreating diaper rash are present in a total concentration of at leastabout 0.1% w even if none of the active ingredients for treating diaperrash is individually present in a concentration of at least about 0.1%w. In the same way, the limitation “at least about 0.001% w of at leastone rheology modifier” is satisfied or met (a) if any rheology modifieris present in a concentration of at least about 0.001% w or (b) if twoor more rheology modifiers are present in a total concentration of atleast about 0.001% w even if none of the rheology modifiers isindividually present in a concentration of at least about 0.001% w.

[0161] Other limitations specifying at least a certain weight percent ofat least one of a certain type of ingredient should be understood thatsame way (making allowances, of course, for different numerical limitsand types of ingredients). For example, the limitation “at least about0.1% w of at least one film-forming agent” is satisfied or met (a) ifany film-forming agent is present in a concentration of at least about0.1% w or (b) if two or more film-forming agents are present in a totalconcentration of at least about 0.1% w even if none of the film-formingagents is individually present in a concentration of at least about 0.1%w.

[0162] If dimethicone is used, it will typically be present in thecomposition in a concentration range of about 0.01% w to about 30% w,desirably in a range of about 0.1% w to about 10% w, and preferably in arange of about 0.2% w to about 3% w. If zinc oxide is used, it willtypically be present in a concentration range of about 0.01% w to about40% w, desirably in a range of about 0.1% w to about 20% w, andpreferably in a range of about 0.2% w to about 15% w. If mineral oil isused, it will typically be present in the composition in a concentrationrange of about 10% w to about 99% w, desirably in a range of about 50% wto about 85% w, and preferably in a range of about 55% w to about 80% w.

[0163] The dimethicone used will desirably be a crystal clear viscousliquid, free from suspended matter, and with very little odor. Anydimethicone can be used. One dimethicone found suitable has a viscosityin the range of about 333 to about 368 centistokes when measured using aUbbelhode Size 3 viscometer at 25 degrees Centigrade and a specificgravity of about 0.96 to about 0.98 (25 degrees Centigrade/25 degreesCentigrade).

[0164] The zinc oxide used will desirably be a high purity USP (UnitedStates Pharmacopoeia) zinc oxide with a typical particle size of about0.11 microns, a maximum particle size of about 0.14 microns, a minimumsurface area (BET) of about 8 square meters per gram, a typical surfacearea (BET) of about 9 square meters per gram, a bulk density of about 50pounds per cubic foot (0.80 grams per cubic centimeter), an apparentdensity of about 16 pounds per cubic foot (0.26 grams per cubiccentimeter), and with about 99.99% of the particles passing through a325 mesh screen. Thus, the zinc oxide used herein will typically have anaverage particle size of less than about 1 micron (desirably less thanabout 0.75 microns, more desirably less than about 0.50 microns, mostdesirably less than about 0.25 microns, preferably less than about 0.20microns, and more preferably less than about 0.15 microns) and a BETsurface area of at least about 5 square meters per gram. The zinc oxideparticle size (and the size of any other particulates in thecomposition) should not be so large as to prevent the composition frombeing spray-pumpable.

[0165] The mineral oil is desirably light mineral oil NF (NationalFormulary) and is a colorless, odorless, transparent oil liquid. Itsviscosity will desirably be in the range of about 7 to about 10centistokes when measured using a Ubbelhode Size 2 viscometer at 40degrees Centigrade, with a specific gravity of about 0.83 to about 0.84(25 degrees Centigrade/25 degrees Centigrade).

[0166] The concentration of the one or more rheology modifiers should beat least about 0.001% w, usually at least about 0.01% w, desirably atleast about 0.1% w, and preferably at least about 1% w. In some cases,the concentration will be at least about 5% w, at least about 10% w, oreven at least about 20% w.

[0167] The term “rheology modifier” includes waxes and associativethickeners. The term “rheology modifier” also includes other substancesthat are now or may in the future be useful as rheology modifiers,provided they can be successfully used alone or in combination withother rheology modifiers to form a composition of this invention. Theone or more rheology modifiers help impart the desired transportproperties to the composition, that is, they help make the compositionfor example, pseudoplastic or thixotropic, so that it is spray-pumpablebut able to resist running after it has been applied to the skin.

[0168] The wax, if used, is desirably a mineral wax. If mineral wax isused, it will typically be present in the composition in a concentrationrange of about 0.01% w to about 20% w, desirably in a range of about0.1% w to about 15% w, and preferably in a range of about 0.2% w toabout 6% w. The mineral wax will typically be a white to yellowishodorless waxy solid, desirably having a melting range of from about 65degrees Centigrade to about 71 degrees Centigrade.

[0169] The associative thickener, if used, desirably comprises a silicaand preferably colloidal silicon dioxide NF (National Formulary). Itsparticle size cannot be so large as to prevent the composition frombeing spray-pumpable.

[0170] Desirably the mineral wax and colloidal silicon dioxide are bothused. The wax helps give the composition some body, provides internalcohesiveness (internal tack) to the layer of composition on the skin(which facilitates removal from the skin), and provides waterrepellency, in addition to acting as a rheology modifier. The colloidalsilicon dioxide acts as a rheology modifier and if zinc oxide is presentin the composition, the silicon dioxide helps to suspend the zinc oxideparticles. As between these two types of rheology modifiers (waxes andassociative thickeners), the associative thickeners are believed to playa larger role in giving the composition of this invention the desiredtransport properties to make it, for example, pseudoplastic orthixotropic.

[0171] The carrier can comprise more than one ingredient. Theconcentration of the carrier in the composition should be at least about10% w, usually at least about 20% w, desirably at least about 30% w,preferably at least about 40% w, more preferably at least about 50% w,and most preferably at least about 60% w.

[0172] The term “carrier” includes mineral oil and mineral oilreplacements. The term “carrier” also includes other substances that arenow or may in the future be useful as carriers, provided they can besuccessfully used alone or in combination with other carrier ingredientsto form a composition of this invention.

[0173] Mineral oil replacements include alkanes having at least 10carbon atoms (e.g., isohexadecane), benzoate esters, aliphatic esters,noncomodogenic esters, volatile silicone compounds (e.g.,cyclomethicone), and volatile silicone substitutes. Examples of benzoateesters include C₁₂-C₁₅ alkyl benzoate, isostearyl benzoate, 2-ethylhexyl benzoate, dipropylene glycol benzoate, octyldodecyl benzoate,stearyl benzoate, and behenyl benzoate. Examples of aliphatic estersinclude C₁₂-C₁₅ alkyl octonoate and dioctyl maleate. Examples ofnoncomodogenic esters include isononyl isononanoate, isodecylisononanoate, diisostearyl dimer dilinoleate, arachidyl propionate, andisotridecyl isononanoate. Examples of volatile silicone substitutesinclude isohexyl decanoate, octyl isononanoate, isononyl octanoate, anddiethylene glycol dioctanoate.

[0174] If mineral oil is used, it will typically be present in thecomposition in a concentration range of about 10% w to about 99% w,desirably in a range of about 50% w to about 85% w, and preferably in arange of about 55% w to about 80% w.

[0175] If isohexadecane is used, it will typically be present in thecomposition in a concentration range of about 0.01% w to about 50% w,desirably in a range of about 0.1% w to about 15% w, and preferably in arange of about 0.2% w to about 10% w. The isohexadecane helps reduce thegreasiness of the composition that might be felt if it were not present.Isohexadecane by itself tends to feel “dry” and not greasy.

[0176] If cyclomethicone is used, it will typically be present in thecomposition in a concentration range of about 0.01% w to about 99% w,desirably in a range of about 0.1% w to about 20% w, and preferably in arange of about 0.2% w to about 15% w. Cyclomethicone is an evaporativesilicone and it helps make the composition spray-pumpable. Furthermore,after the composition is dispensed and contacts the skin, thecyclomethicone tends to evaporate, thereby helping to the composition toresist running and thereby fix the composition on the skin on which itwas sprayed.

[0177] Preferably the carrier comprises a combination of mineral oil,isohexadecane, and cyclomethicone.

[0178] Desirably at least one film-forming agent is used in thecomposition. The concentration of the one or more film-forming agentsshould be at least about 0.001% w, usually at least about 0.01% w,desirably at least about 0.1% w, more desirably at least about 0.2% w,preferably at least about 1% w, and more preferably at least about 2% w.In some cases, the concentration will be at least about 5% w, at leastabout 10% w, or even at least about 20% w.

[0179] The term “film-forming agent” includes polymers such assilicone-containing polymers and synthetic waxes. The term “film-formingagent” also includes other substances that are now or may in the futurebe useful as film-forming agents, provided they can be successfully usedalone or in combination with other film-forming agents to form acomposition of this invention.

[0180] The silicone-containing polymers that are useful herein willtypically have silicone-seeking groups and hydrophobic groups. Anexample of a silicone-containing polymer that may be used as afilm-forming agent is a polydimethylsiloxane-polypropylene glycolether/isopropyldiisocyanate copolymer, which is a silicone polyurethaneand is described as a semi-clear faint yellow viscous liquid. Such amaterial is marketed under the name Polyderm PPI-SI-WI by Alzo Inc.,located in Matawan, N.J., United States. If that silicone-containingpolymer is used, it will typically be present in the composition in aconcentration range of about 0.01% w to about 15% w, desirably in arange of about 0.1% w to about 10% w, and preferably in a range of about0.2% w to about 3% w. This polymer functions not only as a film-formingagent but also is a conditioner and emollient, helps impartwater-resistance, and helps provide adherence of the composition to theskin. This polymer also helps couple the silicone-containing componentspresent (e.g., dimethicone and cyclomethicone) to thenon-silicone-containing ingredients present (e.g., mineral oil).

[0181] An example of a synthetic wax that may be used as a film-formingagent is described as a highly branched hydrocarbon manufactured fromolefins. A suitable synthetic wax may have a polydispersity of about2.4, a number average molecular weight of about 900, and a weightaverage molecular weight of about 2,200. One such suitable material ismarketed under the name Performa V 825 Polymer by New Phase Technologieslocated in Piscataway, N.J., United States. The company's “NPT TechnicalBulletin 6825-1” (revision dated March 1999) describes the material as“an excellent film former and conditioner,” which “provides gloss tolipsticks and improves the rheology of sunscreen formulations.” If thatsynthetic wax is used, it will typically be present in the compositionin a concentration range of about 0.01% w to about 30% w, desirably in arange of about 0.1% w to about 10% w, and preferably in a range of about0.2% w to about 6% w. This synthetic wax functions not only as afilm-forming agent but also helps impart water-resistance.

[0182] Many different optional ingredients may be included in thecomposition, including colorants, fragrances, anti-microbials,preservatives, emollients, conditioners, adherence-promoting agents,water-resistance agents, and water-proofing agents. For example, an aloebarbadensis product may be included as may vitamins such as vitamin E.An aloe product, if used in the composition, will typically be presentin the composition in a concentration range of about 0.01% w to about15% w, desirably in a range of about 0.1% w to about 10% w, andpreferably in a range of about 0.2% w to about 6% w. Vitamin E, if usedin the composition, will typically be present in the composition in aconcentration range of about 0.01% w to about 5% w, desirably in a rangeof about 0.1% w to about 3% w, and preferably in a range of about 0.2% wto about 1% w, and may be added in its acetate ester form.

[0183] A preferred composition without zinc oxide and a preferredcomposition with zinc oxide are shown below (numerical values are weightpercentages). Preferred Composition Preferred Composition IngredientWithout Zinc Oxide With Zinc Oxide Mineral Oil 70.95 66.50 PolydermPPI-SI-WI 1.00 0.50 Dimethicone 1.00 1.00 Mineral Wax 5.00 2.25 PerformaV 825 Polymer 2.00 1.30 Colloidal Silicon Dioxide 2.30 2.10Cyclomethicone 9.00 8.50 Isohexadecane 6.50 5.60 Aloe BarbadensisExtract 2.00 2.00 Vitamin E Acetate 0.25 0.25 Zinc Oxide 0.00 10.00Total 100.00 100.00

[0184] A typical process for manufacturing the preferred compositionwith zinc oxide is as follows. The first five ingredients (mineral oil,Polyderrn PPI-SI-WI, dimethicone, mineral wax, and Performa V 825Polymer) are placed in a suitable stainless steel container and heatedto about 80 degrees Centigrade while mixing at slow speed. After themineral wax melts, heating is halted and the zinc oxide is added whilemixing at about 500 RPM (revolutions per minute) for at least 10minutes. When the batch cools to about 50 degrees Centigrade (whilestill mixing), the colloidal silicon dioxide is added and the mixingspeed is increased to about 2,000 RPM and held at that speed for atleast 20 minutes. The remaining ingredients (cyclomethicone,isohexadecane, aloe barbadensis extract, and vitamin E acetate) are thenadded and mixing is continued for about 15 minutes. At the end of thistime, the material is milled to further homogenize it and themanufacture is then complete. To make the preferred composition thatdoes not contain the zinc oxide, the process is essentially the same,the major difference being that the step in which the zinc oxide isadded is omitted. The processes for making other compositions of theinvention are well within the skill of the art.

[0185] When the composition contains solid suspended particles (e.g.,the zinc oxide and/or colloidal silica), it might be seem to be moreappropriate to refer to the composition as a dispersion or suspensionrather than as a liquid. However, even though solid particles may bepresent, the composition of this invention will still be referred to asa “liquid” because (a) the continuous phase of the composition is liquidand typically will account for the majority of the composition (andpreferably about 90% w of it) and (b) the user will likely perceive sucha composition as being “liquid.”

[0186] For a variety of reasons, such a dispersion or suspension isdesirably storage-stable, that is, the particles desirably do not settleout, even after prolonged standing. When zinc oxide particles arepresent, the silica (e.g., colloidal silicon dioxide) helps preventtheir settling. If particles do settle out, they should be readily andeasily redispersable and resuspendable, preferably merely by shaking thecomposition a few times.

[0187] As will be apparent, a single ingredient can perform more than asingle function in a composition of this invention. Thus, it should beunderstood in applying the claims to a given composition that because aningredient of the composition may perform more than one function, thatone ingredient may thereby satisfy (or meet) more than one limitation ofa claim. For example, mineral oil, which can act as an activeingredient, is also a preferred carrier. If mineral oil is present in acomposition in at least the minimum concentration for an activeingredient for protecting skin specified by the limitation of a givenclaim, then the mineral oil of that composition meets that claimlimitation. If the mineral oil is also present in that composition in atleast the minimum concentration specified for the carrier by anotherlimitation of the same claim, then the mineral oil of that compositionalso meets that limitation of the claim. Thus, the same ingredient andamount of ingredient can satisfy more than a single limitation of aclaim. (If no numerical minimum is specified in a claim limitation thatrequires the presence of an ingredient, for example, a limitation thatjust requires “carrier,” that limitation is satisfied (or met) if atleast some of the ingredient is present.)

[0188] Variations and modifications will be apparent to those skilled inthe art and the claims are intended to cover all modifications andvariations that fall within the true spirit and scope of the invention.

We claim:
 1. A skin-protectant composition comprising: (a) at leastabout 0.001% w of at least one active ingredient for protecting skin;(b) at least about 0.001% w of at least one rheology modifier; and (c)carrier; wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.
 2. The compositionof claim 1 wherein the at least one active ingredient is selected fromthe group consisting of mineral oil, dimethicone, zinc oxide, allantoin,calamine, kaolin, petrolatum, white petrolatum, cod liver oil, lanolin,talc, topical starch, aluminum hydroxide gel, cocoa butter, glycerine,shark liver oil, zinc acetate, and zinc carbonate.
 3. The composition ofclaim 1 wherein the at least one rheology modifier comprises wax.
 4. Thecomposition of claim 3 wherein the wax comprises mineral wax.
 5. Thecomposition of claim 4 wherein the mineral wax has a melting range offrom about 65 degrees Centigrade to about 71 degrees Centigrade.
 6. Thecomposition of claim 1 wherein the at least one rheology modifiercomprises an associative thickener.
 7. The composition of claim 6wherein the associative thickener comprises silica.
 8. The compositionof claim 7 wherein the silica comprises colloidal silicon dioxide. 9.The composition of claim 1 wherein the at least one rheology modifiercomprises wax and an associative thickener.
 10. The composition of claim9 wherein the wax comprises mineral wax and the associative thickenercomprises silica.
 11. The composition of claim 10 wherein the mineralwax has a melting range of from about 65 degrees Centigrade to about 71degrees Centigrade and the silica comprises colloidal silicon dioxide.12. The composition of claim 1 wherein the carrier comprises mineral oilor a mineral oil replacement.
 13. The composition of claim 12 whereinthe carrier comprises a mineral oil replacement selected from the groupconsisting of alkanes having at least 10 carbon atoms, benzoate esters,aliphatic esters, noncomodogenic esters, volatile silicone compounds,and volatile silicone substitutes.
 14. The composition of claim 1further comprising at least one film-forming agent.
 15. The compositionof claim 14 wherein the at least one film-forming agent comprises apolymer.
 16. The composition of claim 15 wherein the polymer comprises asilicon-containing polymer.
 17. The composition of claim 15 wherein thepolymer comprises synthetic wax.
 18. The composition of claim 1 whereinthe at least one active ingredient for protecting skin comprises anactive ingredient for treating diaper rash.
 19. The composition of claim18 wherein the active ingredient for treating diaper rash is selectedfrom the group consisting of mineral oil, dimethicone, zinc oxide,allantoin, calamine, kaolin, petrolatum, white petrolatum, cod liveroil, lanolin, talc, and topical starch.
 20. A skin-protectantcomposition comprising: (a) at least about 0.001% w of at least oneactive ingredient for protecting skin; (b) at least about 0.001% w of arheology modifier that is an associative thickener and optionally atleast about 0.001% w of at least one additional rheology modifier; and(c) carrier; wherein the composition is liquid, is water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.
 21. The compositionof claim 20 wherein the associative thickener comprises silica.
 22. Thecomposition of claim 21 wherein the at least one additional rheologymodifier is present in the composition and comprises wax.
 23. Thecomposition of claim 21 wherein the silica comprises colloidal silicondioxide.
 24. The composition of claim 23 wherein the at least oneadditional rheology modifier is present in the composition and compriseswax.
 25. The composition of claim 20 further comprising at least onefilm-forming agent.
 26. The composition of claim 25 wherein the at leastone film-forming agent comprises a polymer.
 27. The composition of claim26 wherein the polymer comprises a silicon-containing polymer.
 28. Thecomposition of claim 26 wherein the polymer comprises synthetic wax. 29.The composition of claim 20 wherein the at least one active ingredientis selected from the group consisting of mineral oil, dimethicone, zincoxide, allantoin, calamine, kaolin, petrolatum, white petrolatum, codliver oil, lanolin, talc, topical starch, aluminum hydroxide gel, cocoabutter, glycerine, shark liver oil, zinc acetate, and zinc carbonate.30. The composition of claim 20 wherein the carrier comprises mineraloil or a mineral oil replacement.
 31. The composition of claim 30wherein the carrier comprises a mineral oil replacement selected fromthe group consisting of alkanes having at least 10 carbon atoms,benzoate esters, aliphatic esters, noncomodogenic esters, volatilesilicone compounds and volatile silicone substitutes.
 32. Thecomposition of claim 20 wherein the at least one active ingredient forprotecting skin comprises an active ingredient for treating diaper rash.33. The composition of claim 32 wherein the active ingredient fortreating diaper rash is selected from the group consisting of mineraloil, dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum,white petrolatum, cod liver oil, lanolin, talc, and topical starch. 34.A skin-protectant composition comprising: (a) at least about 0.001% w ofat least one active ingredient for protecting skin; (b) at least about0.001% w of a rheology modifier that is an associative thickener andoptionally at least about 0.001% w of at least one additional rheologymodifier; (c) at least about 0.001% w of at least one film-formingagent; and (d) carrier; wherein the composition is liquid, iswater-repellent, is substantially anhydrous, is spray-pumpable, isdesigned for spraying onto the skin of a baby or other human forprotecting the skin, has suitable adherence to the skin, and resistsrunning.
 35. The composition of claim 34 wherein the associativethickener comprises silica.
 36. The composition of claim 35 wherein theat least one additional rheology modifier is present in the compositionand comprises wax.
 37. The composition of claim 35 wherein the silicacomprises colloidal silicon dioxide.
 38. The composition of claim 37wherein the at least one additional rheology modifier is present in thecomposition and comprises wax.
 39. The composition of claim 34 whereinthe at least one film-forming agent comprises a polymer.
 40. Thecomposition of claim 39 wherein the polymer comprises asilicon-containing polymer.
 41. The composition of claim 39 wherein thepolymer comprises synthetic wax.
 42. The composition of claim 34 whereinthe at least one active ingredient is selected from the group consistingof mineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,petrolatum, white petrolatum, cod liver oil, lanolin, talc, topicalstarch, aluminum hydroxide gel, cocoa butter, glycerine, shark liveroil, zinc acetate, and zinc carbonate.
 43. The composition of claim 34wherein the carrier comprises mineral oil or a mineral oil replacement.44. The composition of claim 43 wherein the carrier comprises a mineraloil replacement selected from the group consisting of alkanes having atleast 10 carbon atoms, benzoate esters, aliphatic esters, noncomodogenicesters, volatile silicone compounds, and volatile silicone substitutes.45. The composition of claim 34 wherein the at least one activeingredient for protecting skin comprises an active ingredient fortreating diaper rash.
 46. The composition of claim 45 wherein the activeingredient for treating diaper rash is selected from the groupconsisting of mineral oil, dimethicone, zinc oxide, allantoin, calamine,kaolin, petrolatum, white petrolatum, cod liver oil, lanolin, talc, andtopical starch.
 47. A skin-protectant composition comprising: (a) atleast about 0.1% w of at least one active ingredient for protectingskin; (b) at least about 0.1% w of a rheology modifier that is anassociative thickener comprising silica and optionally at least about0.1% w of at least one additional rheology modifier; (c) at least about0.1% w of at least one polymeric film-forming agent; and (d) carrier;wherein the composition is liquid, is water-repellent, is substantiallyanhydrous, is spray-pumpable, is designed for spraying onto the skin ofa baby or other human for protecting the skin, has suitable adherence tothe skin, and resists running.
 48. The composition of claim 47 whereinthe at least one additional rheology modifier is present in thecomposition and comprises wax.
 49. The composition of claim 47 whereinthe at least one polymeric film-forming agent comprises asilicon-containing polymer.
 50. The composition of claim 47 wherein theat least one polymeric film-forming agent comprises synthetic wax. 51.The composition of claim 47 wherein the at least one active ingredientis selected from the group consisting of mineral oil, dimethicone, zincoxide, allantoin, calamine, kaolin, petrolatum, white petrolatum, codliver oil, lanolin, talc, topical starch, aluminum hydroxide gel, cocoabutter, glycerine, shark liver oil, zinc acetate, and zinc carbonate.52. The composition of claim 47 wherein the carrier comprises mineraloil or a mineral oil replacement.
 53. The composition of claim 52wherein the carrier comprises a mineral oil replacement selected fromthe group consisting of alkanes having at least 10 carbon atoms,benzoate esters, aliphatic esters, noncomodogenic esters, volatilesilicone compounds, and volatile silicone substitutes.
 54. Thecomposition of claim 47 wherein the at least one active ingredient forprotecting skin comprises an active ingredient for treating diaper rash.55. The composition of claim 54 wherein the active ingredient fortreating diaper rash is selected from the group consisting of mineraloil, dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum,white petrolatum, cod liver oil, lanolin, talc, and topical starch. 56.A skin-protectant composition comprising: (a) at least about 0.001% w ofat least one active ingredient for protecting skin; (b) at least about0.001% w of at least one rheology modifier that is an associativethickener and optionally at least about 0.001% w of at least oneadditional rheology modifier that is a wax; (c) at least about 0.001% wof at least one polymeric film-forming agent selected from the groupconsisting of silicon-containing polymers and synthetic waxes; and (d)carrier; wherein the composition is liquid, water-repellent, issubstantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for protecting the skin, hassuitable adherence to the skin, and resists running.
 57. The compositionof claim 56 wherein the at least one additional rheology modifier thatis a wax is present in the composition.
 58. The composition of claim 57wherein the wax comprises mineral wax.
 59. The composition of claim 56wherein the associative thickener comprises silica.
 60. The compositionof claim 59 wherein the silica comprises colloidal silicon dioxide. 61.The composition of claim 56 wherein the carrier comprises mineral oil ora mineral oil replacement.
 62. The composition of claim 61 wherein thecarrier comprises a mineral oil replacement selected from the groupconsisting of alkanes having at least 10 carbon atoms, benzoate esters,aliphatic esters, noncomodogenic esters, volatile silicone compounds,and volatile silicone substitutes.
 63. The composition of claim 56wherein the at least one polymeric film-forming agent comprises both asilicone-containing polymer and a synthetic wax.
 64. The composition ofclaim 56 wherein the at least one active ingredient is selected from thegroup consisting of mineral oil, dimethicone, zinc oxide, allantoin,calamine, kaolin, petrolatum, white petrolatum, cod liver oil, lanolin,talc, topical starch, aluminum hydroxide gel, cocoa butter, glycerine,shark liver oil, zinc acetate, and zinc carbonate.
 65. The compositionof claim 56 wherein the carrier comprises mineral oil or a mineral oilreplacement.
 66. The composition of claim 65 wherein the carriercomprises a mineral oil replacement selected from the group consistingof alkanes having at least 10 carbon atoms, benzoate esters, aliphaticesters, noncomodogenic esters, volatile silicone compounds, and volatilesilicone substitutes.
 67. The composition of claim 56 wherein the atleast one active ingredient for protecting skin comprises an activeingredient for treating diaper rash.
 68. The composition of claim 67wherein the active ingredient for treating diaper rash is selected fromthe group consisting of mineral oil, dimethicone, zinc oxide, allantoin,calamine, kaolin, petrolatum, white petrolatum, cod liver oil, lanolin,talc, and topical starch.
 69. A diaper rash composition comprising: (a)at least about 0.1% w of at least one active ingredient for treatingdiaper rash; (b) at least about 0.1% w of at least one rheologymodifier; (c) at least about 0.1% w of at least one film-forming agent;and (d) carrier; wherein the composition is liquid, is water-repellent,is substantially anhydrous, is spray-pumpable, is designed for sprayingonto the skin of a baby or other human for treating diaper rash, hassuitable adherence to the skin, and resists running.
 70. A diaper rashcomposition comprising: (a) at least about 1% w of dimethicone; (b) atleast about 0.5% w of at least one rheology modifier selected from thegroup consisting of associative thickeners and waxes; (c) at least about0.2% w of at least one polymeric film-forming agent; and (d) carrier;wherein the composition is liquid, is water-repellent, is substantiallyanhydrous, is spray-pumpable, is designed for spraying onto the skin ofa baby or other human for treating diaper rash, has suitable adherenceto the skin, and resists running.
 71. A diaper rash compositioncomprising: (a) at least about 1% w of dimethicone; (b) at least about1% w of zinc oxide; (c) at least about 1% w of wax; (d) at least about1% w of an associative thickener; (e) at least about 0.2% w of at leastone polymeric film-forming agent; and (f) carrier selected from thegroup consisting of mineral oil and mineral oil replacements; whereinthe composition is liquid, is water-repellent, is substantiallyanhydrous, is spray-pumpable, is designed for spraying onto the skin ofa baby or other human for treating diaper rash, has suitable adherenceto the skin, and resists running.
 72. A diaper rash compositioncomprising: (a) at least about 1% w of dimethicone; (b) at least about1% w of mineral wax; (c) at least about 0.5% w of silica; (d) at leastabout 0.1% w of a silicon-containing polymeric film-forming agent; (e)at least about 0.1% w of a synthetic wax polymeric film-forming agent;(f) at least about 2% w cyclomethicone; (g) at least about 2% wisohexadecane; and (h) at least about 50% w mineral oil; wherein thecomposition is liquid, is water-repellent, is substantially anhydrous,is spray-pumpable, is designed for spraying onto the skin of a baby orother human for treating diaper rash, has suitable adherence to theskin, and resists running.
 73. A diaper rash composition comprising: (a)from about 0.8% w to about 1.2% w of dimethicone; (b) from about 4% w toabout 6% w of mineral wax; (c) from about 1.8% w to about 2.8% w ofsilica; (d) from about 0.8% w to about 1.2% w of a silicon-containingpolymeric film-forming agent; (e) from about 1.6% w to about 2.4% w of asynthetic wax polymeric film-forming agent; (f) from about 7.2% w toabout 10.8% w cyclomethicone; (g) from about 5.2% w to about 7.8% wisohexadecane; and (h) from about 57% w to about 85% w mineral oil;wherein the composition is liquid, is water-repellent, is substantiallyanhydrous, is spray-pumpable, is designed for spraying onto the skin ofa baby or other human for treating diaper rash, has suitable adherenceto the skin, and resists running.
 74. A diaper rash compositioncomprising: (a) at least about 1% w of dimethicone; (b) at least about1% w of zinc oxide; (c) at least about 1% w of mineral wax; (d) at leastabout 0.5% w of silica; (e) at least about 0.1% w of asilicon-containing polymeric film-forming agent; (f) at least about 0.1%w of a synthetic wax polymeric film-forming agent; (g) at least about 2%w cyclomethicone; (h) at least about 2% w isohexadecane; and (i) atleast about 50% w mineral oil; wherein the composition is liquid, iswater-repellent, is substantially anhydrous, is spray-pumpable, isdesigned for spraying onto the skin of a baby or other human fortreating diaper rash, has suitable adherence to the skin, and resistsrunning.
 75. A diaper rash composition comprising: (a) from about 0.8% wto about 1.2% w of dimethicone; (b) from about 8% w to about 12% w ofzinc oxide; (c) from about 1.8% w to about 2.7% w of mineral wax; (d)from about 1.7% w to about 2.5% w of silica; (e) from about 0.4% w toabout 0.6% w of a silicon-containing polymeric film-forming agent; (f)from about 1.0% w to about 1.6% w of a synthetic wax polymericfilm-forming agent; (g) from about 6.8% w to about 10.2% wcyclomethicone; (h) from about 4.5% w to about 6.7% w isohexadecane; and(i) from about 53% w to about 80% w mineral oil; wherein the compositionis liquid, is water-repellent, is substantially anhydrous, isspray-pumpable, is designed for spraying onto the skin of a baby orother human for treating diaper rash, has suitable adherence to theskin, and resists running.
 76. A hand-held spray pump dispensercontaining the composition of any of claims 1 to 75 for spraying thecomposition.
 77. A method of protecting human skin comprising applyingthe composition of any of claims 1 to 75 to human skin.
 78. A method oftreating diaper rash in a human comprising applying the composition ofany of claims 1 to 75 to human skin.